Mindfulness-Based Cognitive Therapy as Migraine Intervention: a Randomized Waitlist Controlled Trial

Abstract Background Based on promising effects seen in a pilot study evaluating a generic mindfulness-based program for migraine, we developed a migraine-specific adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The aim of this study was to evaluate this program for feasibility and effectiveness in a randomized controlled trial. Method Fifty-four patients suffering from migraine were randomly allocated to either waitlist or the adapted MBCT. Outcomes were migraine-related parameters as well as variables of psychological functioning and coping. Assessment took place at baseline and post-intervention, for the intervention group also at follow-up (7 months). The effects of the intervention were analyzed by the use of ANCOVAs and linear mixed models. Results With respect to migraine parameters we did not find a significant group difference in the primary outcome (headache-related impairment), but the intervention resulted in a significant reduction of headache frequency (p = .04). In the analysis of secondary outcomes, MBCT showed superiority in four out of eight psychological parameters (perceived stress, anxiety, rumination, catastrophizing) with small to medium effect sizes. The intervention proved to be feasible and participants reported high degrees of contentment and achievement of personal goals. Conclusions The migraine-specific MBCT program did not result in improvements with regard to headache-related impairment but showed a reduction in headache frequency as well as improved psychological functioning in secondary outcomes. Trial Registration This trial was registered in the German Trial Registry “Deutsches Register Klinischer Studien” (ID: DRKS00007477), which is a WHO-listed primary trial register.

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OS10.4.A The effects of SmartCare on neuro-oncology family caregivers’ distress: a randomized controlled trial

Neuro-Oncology ◽

10.1093/neuonc/noab180.042 ◽

2021 ◽

Vol 23 (Supplement_2) ◽

pp. ii13-ii13

Author(s):

F W Boele ◽

J M Weimer ◽

J Proudfoot ◽

A L Marsland ◽

T S Armstrong ◽

...

Keyword(s):

Depressive Symptoms ◽

Family Caregivers ◽

Behavioral Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Symptom Burden ◽

Significant Group ◽

Intention To Treat ◽

Secondary Outcomes ◽

Physical Consequences

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. MATERIAL AND METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

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The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

International Journal of Social Psychiatry ◽

10.1177/0020764017693652 ◽

2017 ◽

Vol 63 (3) ◽

pp. 212-223 ◽

Cited By ~ 7

Author(s):

Abdalhadi Hasan ◽

Mahmoud Musleh

Keyword(s):

Randomized Controlled Trial ◽

Psychiatric Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Post Intervention ◽

Treatment As Usual ◽

Randomized Controlled ◽

Secondary Outcomes ◽

The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

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QOLP-29. THE EFFECTS OF AN ONLINE, NURSE-LED NEEDS-BASED SUPPORT PROGRAM ON NEURO-ONCOLOGY FAMILY CAREGIVERS' DISTRESS: A RANDOMIZED CONTROLLED TRIAL

Neuro-Oncology ◽

10.1093/neuonc/noab196.749 ◽

2021 ◽

Vol 23 (Supplement_6) ◽

pp. vi189-vi189

Author(s):

Florien Boele ◽

Paula Sherwood ◽

Jason Weimer ◽

Judith Proudfoot ◽

Anna Marsland ◽

...

Keyword(s):

Depressive Symptoms ◽

Family Caregivers ◽

Behavioral Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Symptom Burden ◽

Support Program ◽

Significant Group ◽

Intention To Treat ◽

Secondary Outcomes

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

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Promoting the Quality of Teacher-Toddler Interactions: A Randomized Controlled Trial of “Thrive by Three” In-Service Professional Development in 187 Norwegian Toddler Classrooms

Frontiers in Psychology ◽

10.3389/fpsyg.2021.778777 ◽

2021 ◽

Vol 12 ◽

Author(s):

Elisabet Solheim Buøen ◽

Ratib Lekhal ◽

Stian Lydersen ◽

Turid Suzanne Berg-Nielsen ◽

May Britt Drugli

Keyword(s):

Professional Development ◽

Controlled Trial ◽

Intervention Group ◽

Group Differences ◽

Control Group ◽

Post Intervention ◽

Significant Group ◽

Randomized Controlled ◽

Service Professional

The effectiveness of the Thrive by Three intervention, a 10-month, multicomponent, in-service professional development model to promote the quality of caregiver-toddler interactions (i.e., process quality), was tested utilizing a clustered randomized controlled design. Eighty childcare centers with 187 toddler classrooms in Norway were randomly assigned to either the Thrive by Three intervention group (n=87) or a usual-activity wait list control group (n=100). Interactional quality was assessed with the Toddler version of the Classroom Assessment Scoring System (CLASS-Toddler) at three timepoints: pre-, mid-, and post-intervention. There were significant group differences in change in quality during the intervention period in both CLASS domains, Emotional and Behavioral Support (EBS), and Engaged Support for Learning (ESL), with greater overall differences in the ESL domain. Quality increased in the intervention groups, but quality decreased in the control group from baseline to post-intervention. There were significant group differences in quality at baseline. The Thrive by Three intervention had a positive effect on teacher-toddler interactions in both the EBS and ESL domains. Results need to be replicated preferably in more diverse samples.Clinical Trial Registration:ClinicalTrials.gov #NCT03879733.

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Effects of Teaching Resourcefulness in Patients with Coronary Heart Disease

Western Journal of Nursing Research ◽

10.1177/01939459211020757 ◽

2021 ◽

pp. 019394592110207

Author(s):

Min Wen ◽

Yaqin Liang ◽

Qianqian Shen ◽

Juping Yu ◽

Pingping He ◽

...

Keyword(s):

Coronary Heart Disease ◽

Heart Disease ◽

Health Education ◽

Controlled Trial ◽

Coping Styles ◽

Intervention Group ◽

Control Group ◽

Convenience Sample ◽

Cluster Randomized ◽

And Coping

This cluster randomized controlled trial aimed to investigate the effects of an intervention to teach resourcefulness on depression and coping style of patients with coronary heart disease (CHD). A convenience sample of 72 patients in community settings took part. Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education. Participants in the control group (n = 36) received routine health education only. After the intervention, participants in the intervention group had significantly higher scores on resourcefulness and coping styles, and lower scores on depression than those in the control group (both ps < .001). The findings suggest that a well-developed intervention to teach resourcefulness could help patients with CHD to be more resourceful, improve their level of depression, and choose more effective strategies to cope with stress.

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A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18147510 ◽

2021 ◽

Vol 18 (14) ◽

pp. 7510

Author(s):

Guillermo García Pérez de Sevilla ◽

Olga Barceló Guido ◽

María de la Paz De la Cruz ◽

Ascensión Blanco Fernández ◽

Lidia B. Alejo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Effect Size ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Nutrition Intervention ◽

Sitting Time ◽

Post Intervention ◽

University Employees ◽

Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

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Hybrid Tele and In-Clinic Occupation Based Intervention to Improve Women’s Daily Participation after Breast Cancer: A Pilot Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18115966 ◽

2021 ◽

Vol 18 (11) ◽

pp. 5966

Author(s):

Khawla Loubani ◽

Rachel Kizony ◽

Uzi Milman ◽

Naomi Schreuer

Keyword(s):

Breast Cancer ◽

Cognitive Abilities ◽

Controlled Trial ◽

Intervention Group ◽

Performance Measure ◽

Control Group ◽

Activity Levels ◽

Emotional Symptoms ◽

Short Period ◽

Secondary Outcomes

Background: Women after breast cancer (BC) cope with decreased daily participation and quality of life (QOL) due to physical, cognitive, and emotional symptoms. This study examined a hybrid occupation-based intervention, Managing Participation with Breast Cancer (MaP-BC), to improve daily participation in their meaningful activities. Methods: Thirty-five women after BC phase were randomly allocated to the MaP-BC intervention (n = 18) or control (n = 17) group (standard care only). Assessments were administered at baseline (T1), 6-week (T2), and 12-week (T3) post-T1. Main outcome: perceived performance and performance-satisfaction with meaningful activities according to the Canadian Occupational Performance Measure. Secondary outcomes: retained activity levels (Activity Card Sort), QOL (Functional Assessment of Cancer Therapy-Breast), cognitive abilities (Montreal Cognitive Assessment and Behavior Rating Inventory of Executive Function), and upper-extremity functioning (Disability of Arm, Shoulder, Hand). Results showed significant interaction (group x time) effects for the primary outcome in performance, F(2,66) = 29.54, p = 0.001, ɳP2 = 0.472, and satisfaction, F(2,66) = 37.15, p = 0.000, ɳP2 = 0.530. The intervention group improved more in performance, t = 5.51, p = 0.0001, d = 1.298, and satisfaction, t = −5.32, p = 0.0001, d = 1.254, than the control group between T1 and T2. Secondary outcomes demonstrated within-group improvements. Conclusion: MaP-BC, a comprehensive occupation-based hybrid intervention tailored to women’s functional daily needs after BC, improved participation in meaningful activities within a short period.

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Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

European Psychiatry ◽

10.1016/j.eurpsy.2016.12.007 ◽

2017 ◽

Vol 42 ◽

pp. 103-110 ◽

Cited By ~ 39

Author(s):

C.I. Mahlke ◽

S. Priebe ◽

K. Heumann ◽

A. Daubmann ◽

K. Wegscheider ◽

...

Keyword(s):

Mental Illness ◽

Peer Support ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Treatment As Usual ◽

Secondary Outcomes ◽

One To One ◽

Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

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Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

10.21203/rs.3.rs-265906/v2 ◽

2021 ◽

Author(s):

Remi Yoshikata ◽

Khin Zay Yar Myint ◽

Hiroaki Ohta ◽

Yoko Ishigaki

Keyword(s):

Randomized Controlled Trial ◽

Visceral Fat ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Climacteric Symptoms ◽

Post Intervention ◽

Randomized Controlled ◽

Menopausal Women ◽

Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

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